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Quality Systems Specialist (GMP, Computer Systems Validation - Must have, Life Cycle Docs Review) job in Central Area at

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Quality Systems Specialist (GMP, Computer Systems Validation - Must have, Life Cycle Docs Review) at

Quality Systems Specialist (GMP, Computer Systems Validation - Must have, Life Cycle Docs Review)

Central Area Permanent
Apply Now

Requirements

·                     Experience to Reviews, Approve computer system validation lifecycle documentations, e.g. IQ, OQ, PQ protocols and reports

·                     Experience to Reviews, Approve computer system validation lifecycle documentations, e.g. risk assessments, tehnical specifications.

·                     Knowledge in Knowledge in 21CFR Part 11 and GAMP5

·                     Experience in coordinate and manage cross functional for the post-execution review,  discrepancy management, status reporting and post-execution approval of all CSV validation documents.

·                     Knowledge in recombinant processes under GMP environment

·                     Hands-on experience with in performing computer systems validation

·                     Hands-on experience with in performing equipment validation

·                     Knowledge in Process Control Systems, preferred Siemens PCS7 platform

·                     Able to logically solve problems in order to find timely solutions

·                     Experience in Quality Management Systems

·                     Proficient in use of MS Office Excel

·                     Proficient in use of MS Office Word

·                     Excellent communication skills (verbal and writing)

·                     Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline

Interested candidates send your cv to [ Email address blocked ]

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

  • Install network hardware and software, including network operating systems
  • Install new hardware/software and maintain existing systems
  • Provide technical assistance to computer system users
  • Supervise computer user support specialists and computer network support specialists
  • Concur systems to end users
  • Provide solutions for software, hardware and systems
  • Utilizing contract management and financial system software and computer systems, including budget control monitoring systems
  • Resolve hardware and software problems from users
  • Deploy the company's software systems
  • Produce system hardware and software documentation including technical drawings
  • Maintain and upgrade internal computer hardware and software systems
  • Resolve hardware and software problems
  • Oversee the daily performance of computer systems
  • Interconnect seamlessly with diverse systems including associated validation systems, file servers, email servers, computer conferencing systems, application servers, and administrative systems
  • Maintain desktop hardware and network systems per Corporate MIS
  • Provide backup support to all system users
  • Evaluate new end user software, hardware or new services
  • Assist with server support or network cabling support
  • Provide support for all financial systems
  • Perform systems trend data analysis

Recommended Skills

  • Administration
  • Biology
  • Biotechnology
  • Chemical Engineering
  • Chemistry
  • Communication

EA License No.

99C4599

EA Personal Registration No.

R1551708
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